1. The impact of riociguat on clinical parameters and quality of life in patients with chronic thromboembolic pulmonary hypertension - results of a retrospective clinical registry
- Author
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Jan Kuchar, Jaroslav Lindner, Pavel Jansa, Vladimír Dytrych, David Ambroz, and Aleš Linhart
- Subjects
medicine.medical_specialty ,Hypertension, Pulmonary ,030204 cardiovascular system & hematology ,Riociguat ,General Biochemistry, Genetics and Molecular Biology ,New york heart association ,Nyha class ,chronic thromboembolic pulmonary hypertension ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Internal medicine ,medicine ,Humans ,Clinical registry ,In patient ,Registries ,Survival rate ,Retrospective Studies ,clinical parameters ,business.industry ,real-world population ,Pyrimidines ,Treatment Outcome ,quality of life ,030220 oncology & carcinogenesis ,riociguat ,Chronic Disease ,Pyrazoles ,Medicine ,Chronic thromboembolic pulmonary hypertension ,Pulmonary Embolism ,business ,medicine.drug - Abstract
Aims. The primary objective of the registry was to assess the impact of riociguat on clinical parameters and quality of life in patients with chronic thromboembolic pulmonary hypertension (CTEPH) that was inoperable or persistent/recurrent after pulmonary endarterectomy (PEA). In contrast to randomized pivotal trials, this non-interventional registry evaluated the effectiveness and safety of riociguat in a real-world setting. Methods. Retrospective data were collected from patients' charts as recorded in routine clinical practice from the initiation of riociguat therapy up to approximately 5 months and 1 year after this initiation. Results. In total, 51 patients from a single site were enrolled. After 5 months (mean duration) of riociguat treatment, the following improvements from baseline were observed: change of distance in the 6-minute walking distance (6MWD) (P=0.066); change of score from the quality of life questionnaire (EQ5D-5L) (P=0.020), and overall self-assessment of health status (P=0.001). New York Heart Association (NYHA) class improved in 24.3% of patients. After 11.2 months (mean duration) of riociguat treatment, the following improvements from baseline were observed: change of distance in the 6MWD test (P=0.006), and overall self-assessment of health status (P=0.009). NYHA class improved in 46.4% of patients. Riociguat was well tolerated. In total, 4 patients reported side effects, with hospitalization required in one case and 2 patients who had to discontinue the treatment. Annual survival rate was 89.1%. Conclusion. Riociguat improves functional NYHA class, distance in the 6MWD test and quality of life in a real-world patient population.
- Published
- 2021